Preparation Time Of Bioflx Crowns Compared To Zirconia Crowns On Primary Molars

NCT06968767 · tracked via the Priya Life Science Egypt tracker

Sponsor

Cairo University

Phase

Not applicable

Started

2025-06-15

Last updated

2025-05-13

Condition(s) studied

Carious Primary Molars

Investigational drug(s) / intervention(s)

bioflx crownzirconia crown

bioflx crown: (Group A: Preformed Biofix Crown - Assigned Intervention) Crown Selection \& Tooth Preparation: Measure the mesiodistal width using calipers to select an appropriately sized crown. If a mesial or distal wall is missing, use the contralateral tooth for size selection. Choose the crown that closely matches the measured mesiodistal width. Select the smallest crown that preserves proximal contacts using a trial-and-error approach. If crimping is necessary, use Howe's pliers. Perform 1-1.5 mm occlusal reduction using a tapered diamond bur. Reduce proximal areas by approximately 0.5 mm to clear the contact area. Crown Placement \& Cementation: Ensure a snug fit of the selected crown. Apply a thin layer of glass ionomer cement inside the crown. Seat the crown firmly using finger pressure. Have the child bite down gently to ensure proper seating. Final Adjustments \& Cleanup: Remove excess cement with floss or an explorer. Verify the crown's fit, occlusion, and stability.

zirconia crown: Group B: Preformed Zirconia Crown - Assigned Intervention) Crown Selection: Measure the mesiodistal width using calipers to select the appropriate crown. If a mesial or distal wall is missing, use the contralateral tooth for size selection. Choose the one that closely matches the mesiodistal width. Select the smallest crown that preserves proximal contacts. Tooth Preparation: Reduce the occlusal surface by 1.5-2 mm using a tapered diamond bur. Reduce interproximal areas by 1-1.5 mm, ensuring a feather-edge finish. Perform a 1-2 mm subgingival preparation in passively placed fissure bur. Crown Placement \& Passive Fit Check: Place the selected crown on the prepared tooth. Cementation of the Crown: Apply a thin layer of glass ionomer cement inside the crown. Seat the crown with passive finger pressure. Have the child bite down gently to ensure seating.

Study summary

This study aims to evaluate and compare the preparation time required for Bioflx crowns versus zirconia crowns on primary molars through a randomized clinical trial.

• Primary Objective: To compare the preparation time required for Bioflex crowns and zirconia crowns on primary molars in pediatric patients.

• Secondary Objectives:

To evaluate the clinical performance of Bioflex crowns compared to zirconia crowns, including:

Retention, Patient Satisfaction, Parental Satisfaction, Occlusal Wear and Gingival Health.

the main question it aim to answer: Is there a significant difference in the preparation time required for Bioflx crowns compared to zirconia crowns in the primary molars of pediatric patients?

Eligibility

Sex

ALL

Min age

4 Years

Max age

8 Years

Healthy volunteers

Accepted

Inclusion Criteria: * Children aged between 4 and 8 years with a primary molar that needs to be covered by a crown. Medically healthy children (ASA I or II according to the American Society of Anesthesiologists classification). Children whose parent or guardian is willing to sign an informed consent. Children whose parent or guardian are willing to comply with follow-up visits. Frankl's positive and definitely positive patient. Exclusion Criteria: * Molars with severe structural loss that may compromise crown retention. Children with poor oral hygiene that may contribute to higher plaque levels and affect the clinical outcomes of the crown restorations. Children with a history of allergies; known allergies to dental local anesthesia or to the materials used in Biofix crowns. Children with any systemic conditions or disabilities that may affect their ability to participate in the study.

Primary outcome measure(s)

prepration time — time frame: T0: 0 basline, follow up 12 month
measured by stop watch per minutes

Trial sites (1)

Facility	City	Region	Status
Faculty of Dentistry Cairo University	Cairo	Egypt

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06968767 on ClinicalTrials.gov ↗ ← All trials in Egypt